Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01162148
• Other study ID #: rab581710ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: June 21, 2010
• Last updated: July 13, 2010
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2010
• Source: Rabin Medical Center
• Contact: Prof Mordechai R. Kramer M.D R Kramer, MD
• Phone: 972-39377221
• Email: kremerm[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Lung transplantation (LT) is now an established treatment option for patients with a wide variety of end-stage lung diseases- aims to improve quality of life and survival. Pulmonary rehabilitation (PR) is widely recognized as an important component of care of patients with chronic obstructive pulmonary disease (COPD), it improves dyspnea, exercise tolerance, quality of life, and reduces healthcare resource utilization.

The goal of pulmonary rehabilitation following lung transplantation is to enhance the physiological and functional benefits resulting from surgery. Inspiratory muscle Training (IMT) is defined as any intervention with the goal of training the inspiratory muscles. IMT can improve inspiratory muscles strength, endurance and exercise capacity in adults with COPD. IMT provides additional benefits to patients undergoing PR program and is worthwhile even in patients who have already undergone a general exercise reconditioning (GER) program. IMT will provide additional benefits (together or without) PR to patients following lung transplantation. No formal guidelines exist regarding the optimal methods of exercise training component of pulmonary rehabilitation for patients recovering from lung transplantation. This study will evaluate the unique influence of IMT in Patients Following Lung Transplantation.

Description:

The post lung transplant patients will participate in a rehabilitation program for 6 months. Participants in the proposed study will belong to one of four intervention groups:

1. Conventional or regular pulmonary rehabilitation program alone(an exercise program that consist 3 main components: aerobic conditioning, resistance training, and flexibility exercises).

2. Very low load IMT(sham IMT) alone.

3. Conventional or regular pulmonary rehabilitation program + Targeted inspiratory resistive or threshold IMT.

4. Targeted inspiratory resistive or threshold IMT alone.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Post lung transplant patients attending the pulmonary Institute , will be invited to participate,They will be co-operative and able to perform spirometry; and other lung tests.

• Patients will be stable clinically,for at least one month,the patients will be all new to an IMT program.

Exclusion Criteria:

• Patients with cardiac disease,poor compliance,or requirement of supplemental oxygen.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Transplantation
• Respiratory Aspiration

Intervention

Behavioral:
• Conventional or regular pulmonary rehabilitation program alone
Conventional or regular pulmonary rehabilitation program alone

Device:
• very low load IMT (sham IMT) alone
very low load IMT (sham IMT) alone
• Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
• Targeted inspiratory resistive or threshold IMT alone
Targeted inspiratory resistive or threshold IMT alone

Locations

Country	Name	City	State
Israel	Pulmonary Institute Rabin Medical center, Beilinson Hospital	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal exercise capacity	at 9 months after starting interventions	9 months after starting interventions	No
Secondary	Lung function (FEV1, FVC)	9 months after starting interventions	9 months after starting interventions	No